Decree of the Government of the Russian Federation of 1 October 2015 No.1046
“About approval of the federal budget grant policy with regard to Russian organizations as partial reimbursement of expenses for implementation of projects on arrangement and conducting of clinical trials of implantable medical devices as part of the subprogram “Development of Production of Medical Devices” of the government program of the Russian Federation “Development of Pharmaceutical and Medical Industry” for years 2013-2020″

Russian organizations implementing projects on arrangement and conduct of clinical trials of implantable medical devices will be provided with federal grants.
The grants are provided to the organizations registered in the Russian Federation, which have a valid permission for conduct of clinical trials of medical devices included in the list of medical devices implanted in a human body when medical care is delivered as part of the program on state guarantees to deliver free medical care to the citizens approved by the Government of the Russian Federation.
The grants are provided for reimbursement of actual costs incurred not earlier than 1 January 2015 and documented by a Russian organization related to the implementation of a project, provided for by the project business plan:
– for acquisition of reference medical devices;
– for contracts with medical facilities taking part in the implementation of the project;
– for insurance payments for life and health insurance of patients participating in clinical trials of a medical device.
To receive a grant, a business project plan must provide:
– Release and sales of medical devices which passed clinical trials as part of the project to start not later than 3 years from the date of the conclusion of a grant agreement;
– Receipt of revenue from sales of medical devices which passed clinical trials as part of the project not later than 3 years from the date of release and sales of these devices in the amount exceeding the amount of a provided grant not less than 3 times.

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Decree of the Government of the Russian Federation of 1 October 2015 No.1048
“About approval of the federal budget grant policy with regard to Russian organizations as partial reimbursement of expenses for implementation of projects on arrangement of production of medical devices as part of the subprogramme “Development of Production of Medical Devices” of the government programme of the Russian Federation “Development of Pharmaceutical and Medical Industry” for years 2013-2020″

Russian organizations implementing projects on arrangement of high-technology manufacturing of medical devices will be provided with federal grants.
A project is understood to be a set of interconnected events and processes which are time- and resource-limited, aimed at arrangement of high-tech manufacturing of medical devices, inter alia, with the assistance of the third parties in the following areas:
– medical devices implanted in a human body;
– disposable medical devices;
– consumables for medical devices;
– assistive devices for disabled persons and persons with reduced mobility, which are medical devices;
– units for high-potency ion beam radiotherapy;
– medical devices for individual remote monitoring of a patient;
– ophthalmic medical device.
A grant is provided to the organizations which have total revenue from sales of the in-house produced medical devices in 2012-2015 is not less than 100 million rubles.
Maximum size of a grant for one applicant cannot exceed 200 million rubles throughout the validity period of the grant agreement and cannot be more than 50 million rubles in 2015.
To receive a grant a project business plan must provide:
– Release and sales of medical devices to start not later than 3 years from the date of the conclusion of a grant agreement;
– Receipt of revenue from sales of medical devices manufactured as part of the project in the amount exceeding the amount of a provided grant not less than 3 times and not later than 3 years from the date of release and sales of the medical devices as part of the project.